Effect of thiamine on cognitive symptom in the patients with mood disorder in the depression phase under electroconvulsive therapy (clinical trial- double blind)
Effect of thiamine on cognitive symptom in the patients with mood disorder in the depression phase under electroconvulsive therapy.
Design
A randomized clinical trial with control group, with parallel groups, phase 3، with blindness that, 62 patients randomly divided into two groups of 31 subjects with block sizes of 4.
Settings and conduct
The study population included patients referred to the psychiatric ward of Yahya Nejad Hospital who will undergo electroshock therapy (ECT).Patients' cognitive ability will be assessed 24 hours before and 24 hours after the end of ECT sessions and also two months after the end of ECT using the Eden Brook cognitive examination test. The hour after the end of the electroshock therapy sessions and also two months later will be used. This test is performed by a trained tester in 15 to 20 minutes.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 20-50 years with depressive phase of mood disorders
Exclusion Criteria:Patients with a history of alcohol and other substance use in the month before enrollment, Epilepsy, Mental retardation, Cognitive disorders such as delirium and dementia, History of thiamine use in the month before enrollment, Anemia and Malnutrition
Intervention groups
Intervention group: Thiamine (pharmaceutical drug Sanamod) will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks.
Control group: Placebo will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks
Main outcome variables
Cognitive ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043700N3
Registration date:2021-03-12, 1399/12/22
Registration timing:registered_while_recruiting
Last update:2021-03-12, 1399/12/22
Update count:0
Registration date
2021-03-12, 1399/12/22
Registrant information
Name
Romina Hamzehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
r.hamzehpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of thiamine on cognitive symptom in the patients with mood disorder in the depression phase under electroconvulsive therapy (clinical trial- double blind)
Public title
The effectiveness of thiamine on cognitive symptoms after electroconvulsive therapy in patients with mood disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20-50 years with depressive phase of mood disorders
Exclusion criteria:
Patients with a history of alcohol and other substance use in the month before enrollment
Epilepsy
Mental retardation
Cognitive disorders such as delirium and dementia
History of thiamine use in the month before enrollment
Anemia
Malnutrition
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly divided into two groups of 31 subjects with four blocks and an allocation ratio of 1: 1.The free website WWW.randomization .com was used to generate the allocation sequence. The obtained sequence was written on separate sheets and placed in sealed envelopes and given to the main researcher for study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Thiamine tablets are powdered by a mortar and the placebo is filled with flour and poured into separate capsules. The shape, taste, smell and packaging of the drugs are quite similar. A code is assigned to each container of medicine. When the drug is assigned to the patient, the drug code will be entered on the file. At the end of the study, the codes will be opened and the results will be analyzed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.MUBABOL.REC.1399.488
Health conditions studied
1
Description of health condition studied
Cognitive Symptom
ICD-10 code
R41
ICD-10 code description
Other symptoms and signs involving cognitive functions and awareness
Primary outcomes
1
Description
Cognitive ability
Timepoint
It will be measured 24 hours before and 24 hours after the end of electroconvulsive therapy sessions and also two months after the end of electroconvulsive therapy.
Method of measurement
Addenbrooke's Cognitive Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Thiamine (pharmaceutical drug Sanamod) will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo will be started 24 hours before electroconvulsive therapy at a dose of 100 mg daily and this daily dose will continue for up to 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahya Nejad Hospital
Full name of responsible person
Roumina Hamzehpour
Street address
Shahid Mostafa Khomeini St., Modarres St
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3222 5035
Email
r.hamzehpour@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?